ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

NCT02858258 | Recruiting Phase 3 DMC

• 1 other identifier: TRIANGLE
• Study Type: interventional
• Target: 870
• Locations: 5 countries
• Sites: 112

Brief Summary

The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.

Conditions

Mantle Cell Lymphoma

Keywords

MCL

Outcome Measures

Primary Outcomes (1)

• Failure Free Survival

  From start of treatment until stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause, whichever comes first, assessed up to 120 months.

Secondary Outcomes (5)

• Overall Survival

  From start of treatment until the date of first documented progression, assessed up to 120 months.

• Number of participants with treatment-related adverse events as assessed by CTC Version 4.03

  From start of Ibrutinib treatment during induction immuno-chemotherapy and during maintenance and to compare the safety profile of the three treatment arms in terms of secondary toxicity endpoints. Through study conduction, an average of up to 30 months.

• Progression-free survival (PFS)

  PFS is the time to progression or death from any cause. Assed up to 120 months.

• Number of Secondary Primary Malignancies

  From start of treatment through the study conduction, up to 120 months.

• Number of Adverse Events by CTC grade (Version 4.03)

  From start of treatment through the study conduction, up to 120 months.

Study Arms (3)

Standard Arm A

ACTIVE COMPARATOR

R-CHOP/R-DHAP: Alternating 3 cycles of R-CHOP in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP ASCT conditioning (ASCT: autologous stemm cell transplantation) Drug: THAM or BEAM

Drug: R-CHOP/R-DHAP; Drug: ASCT conditioning

Experimental Arm A+I

EXPERIMENTAL

R-CHOP+Ibrutinib/R-DHAP: Alternating 3 cycles of R-CHOP + Ibrutinib at Days 1-19 in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP Drug: Ibrutinib (Induction) ASCT conditioning (ASCT: autologous stemm cell transplantation) Drug: THAM or BEAM 2 years Ibrutinib Maintenance Drug: Ibrutinib (Maintenace)

Drug: R-CHOP/R-DHAP; Drug: Ibrutinib (Induction); Drug: ASCT conditioning; Drug: Ibrutinib (Maintenance)

Experimental Arm I

EXPERIMENTAL

R-CHOP+Ibrutinib / R-DHAP: Alternating 3 cycles of R-CHOP + Ibrutinib at Days1-19 in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP Drug: Ibrutinib (Induction) 2 years Ibrutinib Maintenance Drug: Ibrutinib (Maintenance)

Drug: R-CHOP/R-DHAP; Drug: Ibrutinib (Induction); Drug: Ibrutinib (Maintenance)

Interventions

R-CHOP/R-DHAP DRUG

Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)

Also known as: rituximab, CHOP, DHAP

Experimental Arm A+I; Experimental Arm I; Standard Arm A

Ibrutinib (Induction) DRUG

Ibrutinib: only in cycle 1,3,5 on Day 1-19

Also known as: Imbruvica

Experimental Arm A+I; Experimental Arm I

ASCT conditioning DRUG

ASCT conditioning THAM or BEAM, stratified per site before trial activation at site THAM (TBI (total body irradiation), Ara-C, Melphalan) or BEAM (BCNU, Etoposide, Cytarabine, Melphalan)

Also known as: THAM or BEAM

Experimental Arm A+I; Standard Arm A

Ibrutinib (Maintenance) DRUG

Ibrutinib (Maintenance), daily 560 mg for 2 years;

Also known as: Imbruvica

Experimental Arm A+I; Experimental Arm I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must meet the following criteria:
• Histologically confirmed diagnosis of MCL according to WHO classification
• suitable for high-dose treatment including high-dose Ara-C
• Stage II-IV (Ann Arbor)
• Age ≥ 18 years and ≤ 65 years
• Previously untreated MCL
• At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
• ECOG/WHO performance status ≤ 2
• The following laboratory values at screening (unless related to MCL):
• Absolute neutrophil count (ANC) ≥1000 cells/µL
• Platelets ≥100,000 cells/µL
• Transaminases (AST and ALT) ≤3 x upper limit of normal (ULN)
• Total bilirubin ≤2 x ULN unless due to known Morbus Meulengracht \[Gilbert-Meulengracht-Syndrome\])
• Creatinine ≤2 mg/dL or calculated creatinine clearance ≥ 50 mL/min
• Written informed consent form according to ICH/EU GCP and national regulations

You may not qualify if:

• Any potential subject who meets any of the following criteria will be excluded from participating in the study.
• Major surgery within 4 weeks prior to randomization.
• Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg phenprocoumon).
• History of stroke or intracranial hemorrhage within 6 months prior to randomization.
• Requires treatment with strong CYP3A4/5 inhibitors.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
• Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
• Known CNS involvement of MCL
• Clinically significant hypersensitivity (eg, anaphylactic or anaphylactoid reactions to the compound of ibrutinib itself or to the excipients in its formulation)
• Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
• Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
• Serious concomitant disease interfering with a regular therapy according to the study protocol:
• Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN )
• Pulmonary (e.g. chronic lung disease with hypoxemia)
• Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus)

Sponsors & Collaborators

• Prof. Dr. M. Dreyling (co-chairman): lead
• LMU Klinikum: collaborator

Study Sites (112)

Aalborg University Hospital, Dept of Hematology

Aalborg, 9000, Denmark

NOT YET RECRUITING

Aarhus University Hospital, Dept of Hematology

Aarhus C, 8000, Denmark

NOT YET RECRUITING

Rigshospitalet, Clinic of Hematology

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Herlev Hospital, Department of Hematology L121

Herlev, 2730, Denmark

NOT YET RECRUITING

Odense University Hospital, Dept of Hematology X

Odense C, 5000, Denmark

NOT YET RECRUITING

Sjaelland University Hospital, Dept of Hematology

Roskilde, 4000, Denmark

NOT YET RECRUITING

Zentralklinik Augsburg, II. Med. Klinik, Hämatologie int. Onkologie

Augsburg, 86156, Germany

RECRUITING

Onkologische Gemeinschaftspraxis Dr. Janssen/Dr. Reichert in der Ubbo-Emmius-Klinik

Aurich, 26603, Germany

RECRUITING

Klinikum Bayreuth, Klinik f. Onkologie und Hämatologie

Bayreuth, 95445, Germany

RECRUITING

Vivantes Klinikum Am Urban, Klinik f. Innere Medizin, Hämatologie und Onkologie

Berlin, 10967, Germany

RECRUITING

Charité Univ.-Medizin Berlin, Med. Klinik - Hämatologie, Onkologie und Tumorimmunologie

Berlin, 12200, Germany

NOT YET RECRUITING

Helios Klinikum Berlin-Buch, Hämatologie, Onkologie und Tumorimmunologie

Berlin, 13125, Germany

RECRUITING

Knappschaftskrankenhaus Bochum-Langendreer

Bochum, 44892, Germany

RECRUITING

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Diako ev. Diakonie-KH gGmbH, Med. Klinik II, Hämatologie und Onkologie

Bremen, 28239, Germany

RECRUITING

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin II

Chemnitz, 09113, Germany

RECRUITING

Uniklinik Köln, Klinik I für Innere Medizin

Cologne, 50937, Germany

RECRUITING

DONAUISAR Klinikum Deggendorf, Innere Medizin II

Deggendorf, 94469, Germany

RECRUITING

St.-Johannes-Hospital

Dortmund, 44137, Germany

RECRUITING

Gemeinschaftspraxis Dr. Mohm und Prange-Krex - Fachärzte für Innere Medizin und Hämatologie und Onkologie

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Düsseldorf, Klinik f. Hämatologie, Onkologie und klinische Immunologie

Düsseldorf, 40225, Germany

RECRUITING

Marien Hospital Düsseldorf

Düsseldorf, 40479, Germany

RECRUITING

Helios Klinikum Erfurt GmbH, Zentrum f. Innere Medizin u. internistische Onkologie, Hämostaseologie

Erfurt, 99089, Germany

RECRUITING

Universitätsklinikum Erlangen, Med. Klinik 5, Hämatologie und internistische Onkologie

Erlangen, 91054, Germany

RECRUITING

St.-Antonius-Hospital Eschweiler, Klinik für Hämatologie und Onkologie

Eschweiler, 52249, Germany

RECRUITING

Universitätsklinikum Essen, Klinik f. Hämatologie

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Freiburg, Klinik f. Innere Medizin, Hämatologie, Onkologie u. Stammzelltransplantation

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsmedizin Göttingen, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Medizinische Onkologie

Göttingen, 37075, Germany

RECRUITING

Universitätsmedizin Greifswald, Klinik u. Poliklinik f. Innere Medizin C, Hämatologie u. Onkologie-, Transplantationszentrum

Greifswald, 17475, Germany

RECRUITING

Katholisches Krankenhaus Hagen gGmbH, St.-Marien-Hospital, Klinik f. Hämatologie und Onkologie

Hagen, 58095, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf (UKE), II. Med. Klinik u. Poliklinik, Onkologie, Hämatologie, KMT

Hamburg, 20246, Germany

RECRUITING

Asklepios Klinik Altona, II. Med.Abt. f. Hämatologie und internistische Onkologie, Stammzelltransplantation

Hamburg, 22763, Germany

RECRUITING

Universitätsklinikum Heidelberg, Med. Klinik - Innere Medizin V - Hämatologie, Onkologie und Rheumatologie

Heidelberg, 69120, Germany

RECRUITING

Universitätsklinikum des Saarlandes, Klinik f. Innere Medizin I Hämatologie & Onkologie

Homburg, 66421, Germany

RECRUITING

Klinikum Idar-Oberstein GmbH, Medizinische Klinik I

Idar-Oberstein, 55743, Germany

RECRUITING

Universitätsmedizin Jena, Klinik f. Innere Medizin II, Abteilung Hämatologie u. Internistische Onkologie

Jena, 07747, Germany

RECRUITING

Städtisches Klinikum Karlsruhe, Med. Klinik III, Hämatologie und Onkologie

Karlsruhe, 76133, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik f. Innere Medizin II - Hämatologie und Onkologie

Kiel, 24105, Germany

RECRUITING

Gemeinschaftsklinikum Mittelrhein gGmbH, Ev. Stift St. Martin, Klinik f. Innere Medizin

Koblenz, 56068, Germany

RECRUITING

Praxisklinik f. Hämatologie und Onkologie Koblenz

Koblenz, 56068, Germany

RECRUITING

Onkologisch-Hämatologische Praxis Dr. Vehling-Kaiser

Landshut, 84028, Germany

RECRUITING

Klinikum Landshut gGmbH, Med. Klinik III, Hämatologie/Internistische Onkologie

Landshut, 84034, Germany

RECRUITING

Caritas-KHLebach, Gemeinschaftspraxis f. Hämatologie und Onkologie, Onkologisches Zentrum Lebach

Lebach, 66822, Germany

RECRUITING

Universitätsklinikum Leipzig AöR, selbständige Abteilung f. Hämatologie und Internistische Onkologie, Hämostaseologische Ambulanz

Leipzig, 04103, Germany

RECRUITING

Klinikum Lippe GmbH, Onkologie und Hämatologie

Lemgo, 32657, Germany

RECRUITING

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Med. Klinik A

Ludwigshafen, 67063, Germany

RECRUITING

Universitätsklinikum Magdeburg AöR, Klinik f. Hämatologie und Onkologie

Magdeburg, 39120, Germany

RECRUITING

Universitätsmedizin der Univ. Mainz, III. Med. Klinik u. Poliklinik

Mainz, 55131, Germany

RECRUITING

Johannes Wiesling Klinikum Minden, Klinik f. Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

Minden, 32429, Germany

RECRUITING

Klinikum der Universität München, Med. Klinik und Poliklinik III

München, 81377, Germany

RECRUITING

Klinikum Rechts der Isar, III. Med. Klinik - Hämatologie und Onkologie

München, 81675, Germany

RECRUITING

Universitätsklinikum Münster, Med. Klinik A, Translationale Onkologie / Lymphome

Münster, 48149, Germany

RECRUITING

Klinikum Nürnberg,5. Medizinische Klinik, Onkologie / Hämatologie

Nuremberg, 90419, Germany

RECRUITING

Klinikum Oldenburg gGmbH, Med. Klinik II

Oldenburg, 26133, Germany

RECRUITING

Klinikum Ernst von Bergmann Potsdam gGmbH, Zentrum f. Innere Medizin, Klinik f. Hämatologie und Onkologie

Potsdam, 14467, Germany

RECRUITING

KH Barmherzige Brüder, Klinik f. Onkologie und Hämatologie

Regensburg, 93049, Germany

RECRUITING

Universitätsmedizin Rostock, Abt. f. Hämatologie und Onkologie, Klinik und Poliklinik für Innere Medizin

Rostock, 18057, Germany

RECRUITING

Klinikum Stuttgart - Katharinenhospital, Klinik f. Hämatologie und Onkologie

Stuttgart, 70174, Germany

RECRUITING

Robert-Bosch-Krankenhaus, Abt.f. Hämatologie und Onkologie

Stuttgart, 70376, Germany

RECRUITING

Klinikum Traunstein, Hämatologie - Onkologie- Palliativmedizin

Traunstein, 83278, Germany

RECRUITING

Klinikum Mutterhaus der Borromäerinnen gGmbH, Okologisches Zentrum

Trier, 54290, Germany

RECRUITING

Universitätsklinikum Tübingen, Med Klinik I, Innere Medizin II

Tübingen, 72026, Germany

RECRUITING

Universitätsklinikum Ulm, Klinik für Innere Medizin III

Ulm, 89081, Germany

RECRUITING

Klinikum Wolfsburg, Med. Klinik II

Wolfsburg, 38440, Germany

RECRUITING

Universitätsklinikum Würzburg, Med. Klinik u. Poliklinik II /ZIM

Würzburg, 97080, Germany

NOT YET RECRUITING

Azienda Ospedaliera SS. Antonio e Biagio e C. Arrigo, SC Ematologia

Alessandria, 15121, Italy

RECRUITING

Policlinico S. Orsola Malpighi, Istituto di Ematologia e Oncologia Medica Seragnoli

Bologna, 40138, Italy

NOT YET RECRUITING

Comprensorio Sanitario di Bolzano, Ematologia e trapianto di midollo osseo

Bolzano, 39100, Italy

NOT YET RECRUITING

Spedali Civili, Struttura Complessa di Ematologia

Brescia, 25123, Italy

NOT YET RECRUITING

Ospedale Businco, UO Ematologia - CTMO

Cagliari, 09121, Italy

NOT YET RECRUITING

ASO S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo

Cuneo, 12100, Italy

NOT YET RECRUITING

AOU Policlinico Careggi, Unità Funzionale di Ematologia

Florence, 50134, Italy

NOT YET RECRUITING

IRCCS AOU S. Martino - IST, Clinica Ematologia

Genova, 16132, Italy

NOT YET RECRUITING

IRCCS AOU S. Martino - IST, Ematologia

Genova, 16132, Italy

NOT YET RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Ematologia

Meldola (FC), 47014, Italy

NOT YET RECRUITING

Istituto Scientifico San Raffaele, Unità Ricerca Clinica Linfomi

Milan, 20132, Italy

NOT YET RECRUITING

Ospedale Niguarda, Struttura Complessa di Ematologia

Milan, 20162, Italy

NOT YET RECRUITING

Università di Modena e Reggio Emilia Policlinico - COM Centro Oncologico Modenese, Dipartimento di Oncologia ed Ematologia

Modena, 41124, Italy

NOT YET RECRUITING

Ospedale S. Gerardo, Divisione di Ematologia

Monza, 20052, Italy

NOT YET RECRUITING

"IRCCS Istituto Nazionale dei Tumori di Napoli - Pascale", Ematologia Oncologica

Napoli, 80131, Italy

RECRUITING

AOU Maggiore della Carità - Università del Piemonte Orientale, S.C.D.U Ematologia

Novara, 28100, Italy

NOT YET RECRUITING

AO Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia

Palermo, 90146, Italy

NOT YET RECRUITING

IRCCS Fondazione Policlinico San Matteo, Clinica Ematologia

Pavia, 27100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Pisana Ospedale "S.Chiara", Dipartimento di Oncologia Divisione di Ematologia

Pisa, 56126, Italy

NOT YET RECRUITING

Ospedale S. Maria delle Croci, U.O di Ematologia

Ravenna, 48121, Italy

NOT YET RECRUITING

Azienda Ospedaliera Bianchi, Melacrino, Morelli, Divisione di Ematologia

Reggio Calabria, 89125, Italy

NOT YET RECRUITING

Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS, Ematologia

Reggio Emilia, 42123, Italy

NOT YET RECRUITING

Ospedale degli Infermi, U.O. Ematologia

Rimini, 47923, Italy

NOT YET RECRUITING

Policlinico Tor Vergata, UOC Oncoematologia

Roma, 00133, Italy

NOT YET RECRUITING

Università La Sapienza, Ematologia

Roma, 00161, Italy

NOT YET RECRUITING

Casa Sollievo della Sofferenza, U.O. Ematologia

San Giovanni Rotondo, 71013, Italy

NOT YET RECRUITING

A.O. Città della Salute e della Scienza, SC Ematologia

Torino, 10126, Italy

NOT YET RECRUITING

A.O. U. Città della Salute e della Scienza, S C Ematologia U

Torino, 10126, Italy

NOT YET RECRUITING

Ospedale Cà Foncello, U.O.C. Ematologia

Treviso, 31100, Italy

NOT YET RECRUITING

Ospedale Cardinale Panico, Divisione di Ematologia

Tricase, 73054, Italy

NOT YET RECRUITING

ASUI Integrata di Udine, Clinica Ematologia

Udine, 33100, Italy

NOT YET RECRUITING

Ospedale Policlinico G.B. Rossi, "Centro trapianto midollo osseo Ematologia"

Verona, 37134, Italy

RECRUITING

Ospedale S. Bortolo, Ematologia

Vicenza, 36100, Italy

RECRUITING

Haukeland University Hospital , Dept. of Oncology and Medical Physics

Bergen, 5021, Norway

NOT YET RECRUITING

Oslo University Hospital, Dept of Oncology

Oslo, 0310, Norway

NOT YET RECRUITING

Stavanger University Hospital, Division for Hematology&Oncology

Stavanger, 4011, Norway

NOT YET RECRUITING

UNN Tromsø, Oncology Dep

Tromsø, 9038, Norway

NOT YET RECRUITING

St. Olavs Hospital, Department of Oncology

Trondheim, 7006, Norway

NOT YET RECRUITING

Sahlgrenska University Hospital, Section of Hematology and Coagulation, Dept of internal medicine

Gothenburg, 413 45, Sweden

NOT YET RECRUITING

University Hospital, Dept of Hematolgy

Linköping, 581 85, Sweden

RECRUITING

Sunderbyn Hospital, Dept of Medicine

Luleå, 971 80, Sweden

NOT YET RECRUITING

Skane University Hospital

Lund, 221 85, Sweden

RECRUITING

Örebro University Hospital, Dept of Oncology

Örebro, 701 85, Sweden

RECRUITING

Karolinska University Hospital, Center of Hematology

Stockholm, 141 86, Sweden

RECRUITING

Norrland University Hospital, Dept of Oncology

Umeå, 901 85, Sweden

NOT YET RECRUITING

Academic Hospital, Dept of Oncology

Uppsala, 751 85, Sweden

RECRUITING

Related Publications (2)

• Dreyling M, Doorduijn J, Gine E, Jerkeman M, Walewski J, Hutchings M, Mey U, Riise J, Trneny M, Vergote V, Shpilberg O, Gomes da Silva M, Leppa S, Jiang L, Stilgenbauer S, Kerkhoff A, Jachimowicz RD, Celli M, Hess G, Arcaini L, Visco C, van Meerten T, Wirths S, Zinzani PL, Novak U, Herhaus P, Benedetti F, Sonnevi K, Hanoun C, Hanel M, Dierlamm J, Pott C, Klapper W, Gozel D, Schmidt C, Unterhalt M, Ladetto M, Hoster E. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. Lancet. 2024 May 25;403(10441):2293-2306. doi: 10.1016/S0140-6736(24)00184-3. Epub 2024 May 2.

  PMID: 38705160 DERIVED

• Kumar A. What is the role of up-front autologous stem cell transplantation in mantle cell lymphoma? Hematology Am Soc Hematol Educ Program. 2022 Dec 9;2022(1):155-162. doi: 10.1182/hematology.2022000333.

  PMID: 36485104 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab; ibrutinib; Neoadjuvant Therapy; Tromethamine; Maintenance

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Therapeutics; Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Health Care Facilities Workforce and Services

Study Officials

• Martin Dreyling, Prof.

  Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Döndü Gözel

CONTACT

+49 89 4400; Doendue.Goezel@med.uni-muenchen.de

Christian Schmidt, Dr.

CONTACT

+49 89 4400; Christian_Schmidt@med.uni-muenchen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Delegated Person / Coordinating Prinicipal Investigator

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 8, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2026
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (60); NO (5); DK (6); IT (33); SE (8)